Real or Sham Acupuncture Fails in Hot Flash Study

Scores decline, but no evidence of true benefit

Action Points

Note that this randomized trial in women with hot flashes found no difference between accupuncture and sham accupuncture in terms of controlling symptoms.

Be aware that the sham device does create a "needle prick" sensation.

Real acupuncture treatments were not superior to "sham acupuncture" (non-insertive treatments) in controlling hot flashes in menopausal women, a small randomized trial in Australia found.

However, both groups did show an approximately 40% decrease baseline hot flash score at the end of treatment, which was durable when checked again at 3 and 6 months, the authors wrote in the Annals of Internal Medicine.

Moreover, mean hot flash scores were slightly lower in the sham acupuncture group compared to the regular group (15.04 versus 15.36), the difference was not statistically significant and there was an extremely broad confidence interval (mean difference 0.33, 95% CI -1.87 to 2.52, P=0.77), reported Carolyn Ee, MBBS, of the University of Melbourne in Australia, and colleagues.

Ee said that she was not surprised at the findings, which suggest patients with vasomotor symptoms, or hot flashes, may benefit from regular interaction with an empathic therapist.

"We already knew from large studies that acupuncture is superior to no treatment for hot [flashes], but the evidence on its effect compared with sham was inconclusive," she wrote in an email to MedPage Today.

In this study, sensitivity analyses examining missing data (16% of acupuncture group and 13% of sham group were lost to follow-up) estimated that hot flash scores only changed in favor of the sham treatment (intervention effect 2.54, 95% CI 0.14-4.96). The authors added that this would assume that women with missing data in the acupuncture group only had a mean hot flash score 1 SD greater (or 13 points higher) than observed women when treatment was completed, and they said that they considered this implausible.

Ee said that these findings allow clinicians to reassure patients that hot flashes do get better with time, even with a sham treatment that has minor physiological effects.

"The effects of acupuncture for improving hot flushes are unrelated to needling, and women should be informed of this if they ask about its efficacy as a hot [flash] treatment," she said.

Ee's team also found no difference between the groups in mean hot flash severity and frequency, nor in the secondary outcomes of menopause-specific quality of life, anxiety, and depression.

Adverse events were mostly mild and were related to acupuncture (such as bleeding and pain). There was no report of serious adverse events.

This stratified, blinded, parallel, randomized, sham-controlled trial examined 327 women in Australia who were 40 or older who were confirmed in late menopausal transition or postmenopause. They randomized 163 to the acupuncture group and 164 in the sham group -- each receiving 10 treatments over 8 weeks.

Participants were mostly Caucasian and well-educated, with a mean age of 55 years. More women in the sham group reported a previous positive experience with acupuncture. Additional requirements for participation were seven hot flashes per day and meeting the criteria for the Chinese medicine diagnosis of kidney yin deficiency.

Limitations to the study included that the sham device used (the Park sham device) may not be as effective a control because it does create a needle prick sensation as opposed to an inert sham. In addition, the demographics of the sample may mean the results are not generalizable to the larger population, and the authors used a Chinese medicine diagnosis that was simpler than the usual practice.

Women with breast cancer were excluded from the sample, as their hot flashes tend to be more severe, and Ee said they warrant separate research as a group in the future.

"It is important to confirm or refute acupuncture's efficacy for this group, given the fact that breast cancer survivors cannot take hormone replacement therapy and commonly suffer from severe hot [flashes]," she explained.

This study was supported by the National Health and Medical Research Council (NHMRC) of Australia.

Ee is supported by an NHMRC Postgraduate Scholarship.

Pirotta is supported by an NHMRC Career Development Fellowship and reports grants from the NHMRC during the course of the study.

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